Demonstrate equivalency of
clinical and commercial batches of the same drug

Details

The FDA challenged a client
company's drug equivalency claims, so the firm turned to Camargo for
expert assistance. Camargo's team of experts in CMC, pharmacokinetics
and toxicology addressed this problem with a unique solution: the drug
equivalence was demonstrated using interspecies scaling. The team
used the available primate data to create accurate projections about the
drug equivalency, rather than taking traditional approaches which would
have required further studies. The result: positive equivalency results
and a compelling presentation to the FDA.

Value

In addition to the FDA
presentation, Camargo helped the client develop much greater insight into
the overall drug development strategy. The interspecies scaling data was
exhibited in a poster presentation at a major medical meeting, and
investor confidence in the sponsor company soared. In addition,
Camargo's work represented a cost savings of approximately $350,000, as
some of the client's planned drug equivalence studies were no longer
required.